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Table 1 Bispecific antibodies in clinical trials. Information from ClinicalTrials.gov (https://clinicaltrials.gov)

From: Bispecific antibodies and their applications

BsAb Sponsor Formats Targets Biological function Clinical trial × identifier Diseases
Catumaxomab Neovii Biotech Triomab EpCAM × CD3 T cell recruitment, Fc-mediated effector function Approved in EU EpCAM-positive tumor, malignant ascites
  AGO Study Group     Completed phase IIa, NCT00189345 Platinum refractory epithelial ovarian cancer
  AIO-Studien-gGmbH     Phase II, NCT01504256 Gastric adenocarcinomas
  Grupo Español de Investigación en Cáncer de Ovario     Phase II, NCT01246440 Ovarian cancer
  Gustave Roussy     Phase IINCT01784900 Gastric peritoneal carcinomatosis
Ertumaxomab Krankenhaus Nordwest Triomab HER2 × CD3 T cell recruitment, Fc-mediated effector function Phase I/II, NCT01569412 Her2/Neu-positive advanced solid tumors
FBTA05 Technische Universität München TrioMab CD20 × CD3 T cell recruitment Phase I/II,NCT01138579 Leukemia
Blinatumomab Amgen Research (Munich) GmbH BiTE CD3 × CD19 T cell recruitment Approved in USA ALL
  Amgen Research (Munich) GmbH     Phase I, NCT00274742 Relapsed NHL
  Amgen Research (Munich) GmbH     Phase II, NCT01207388 B cell ALL
  Amgen Research (Munich) GmbH     Phase II, NCT01209286 Relapsed/refractory ALL
  National Cancer Institute     Phase I, NCT02568553 NHL
  National Cancer Institute     Phase II, NCT02143414 Adult B-ALL with t(9;22)(q34;q11.2);BCR-ABL1; untreated adult ALL
  National Cancer Institute     Phase III, NCT02003222 BCR-ABL-negative B lineage ALL
Solitomab (MT110, AMG 110) Amgen Research (Munich) GmbH BiTE CD3 × EpCAM T cell recruitment Completed phase I, NCT00635596 Solid tumors
AMG 330 Amgen BiTE CD33 × CD3 T cell recruitment Phase I, NCT02520427 Relapsed/refractory AML
MT112 (BAY2010112) Bayer BiTE PSMA × CD3 T cell recruitment Phase I, NCT01723475 Prostatic neoplasms
MT111 (MEDI-565) MedImmune LLC BiTE CEA × CD3 T cell recruitment Completed phase I, NCT01284231 Gastrointestinal adenocarcinomas
BAY2010112 Bayer BiTE CD3 × PSMA T cell recruitment Phase I, NCT01723475 Prostatic neoplasms
MEDI-565 MedImmune LLC BiTE CEA × CD3 T cell recruitment Completed phase I, NCT01284231 Gastrointestinal adenocarcinomas
MDX447 Dartmouth-Hitchcock Medical Center 2 (Fab’) was crosslinked CD64 × EGFR Active monocytes to kill tumor Completed phase I, NCT00005813 Brain and central nervous system rumors
TF2 Garden State Cancer Center at the Center for Molecular Medicine and Immunology Dock and lock CEA × HSG Enzyme-linked immunosorbent assay Phase I, NCT00895323 Colorectal cancer
  Centre René Gauducheau    Radioimmunotherapy Phase I/II, NCT01221675 Small cell lung cancer
  Nantes University Hospital    Immuno-PET Phase I/II, NCT01730638 Recurrences of medullary thyroid carcinoma
  Nantes University Hospital    Immuno-PET Phase I/II, NCT01730612 HER2 negative breast carcinoma expressing CEA
  Radboud University    Radioimmunotherapy Completed phase I, NCT00860860 Colorectal neoplasms
rM28 University Hospital Tuebingen Tandem scFv CD28 × HMV-MAA Retargeting autologous lymphocytes to tumor Phase I/II, NCT00204594 Malignant melanoma
HER2Bi-aATC Barbara Ann Karmanos Cancer Institute T cells preloaded with bsAbs CD3 × HER2 Activated T cells Phase I, NCT02470559 Ovarian, fallopian tube, or primary peritoneal cancer
GD2Bi-aATC Barbara Ann Karmanos Cancer Institute T cells preloaded with bsAbs CD3 × GD2 Activated T cells Phase I/II, NCT02173093 Children and young adults with neuroblastoma and osteosarcoma
  Barbara Ann Karmanos Cancer Institute     Completed phase I, NCT00938626 Multiple myeloma and plasma cell neoplasm
  Barbara Ann Karmanos Cancer Institute     Completed phase 1, NCT00244946 NHL
EGFRBi-aATC Barbara Ann Karmanos Cancer Institute T cells preloaded with BsAb CD3 × EGFR Autologous activated T cells to EGFR-positive tumor Phase I/II, NCT02521090 Adult brain glioblastoma; adult gliosarcoma; recurrent brain neoplasm
MGD006 MacroGenics DART CD123 × CD3 Retargeting of T cells to tumor Phase I, NCT02152956 Relapsed/refractory AML
MGD007 MacroGenics DART gpA33 × CD3 Retargeting of T cells to tumor Phase I, NCT02248805 Colorectal carcinoma
MGD010 MacroGenics DART CD32B × CD79B   Phase I, NCT02376036 Healthy subjects
Anti-CEAxanti-DTPA Nantes University Hospital scFv-IgG CEA × di-DTPA-131I Radioimmunotherapy Complete phase II, NCT00467506 Medullary thyroid carcinoma
DT2219ARL Masonic Cancer Center 2 scFv linked to diphtheria toxin CD19 × CD22 Targeting of protein toxin to tumor Phase I, NCT00889408 Leukemia; lymphoma
  Masonic Cancer Center     Phase I/II, NCT02370160 Relapsed or refractory B lineage leukemia or lymphoma
IMCgp100 Immunocore Ltd ImmTAC CD3 × gp100 T cell recruitment Phase I, NCT01211262 Malignant melanoma
      Phase I, NCT02570308 Uveal melanoma
Indium-labeled IMP-205xm734 Radboud University Unclear CEA × in-labeled Peptide Nuclear imaging Phase I,NCT0018508 Colorectal cancer
LY3164530 Eli Lilly and Company OrthoFab-IgG MET × EGFR Blockade of 2 receptors Phase I, NCT02221882 Neoplasms; neoplasm metastasis
OMP-305B83 OncoMed Pharmaceuticals, Inc. DVD-Ig DLL4 × VEGF 2-ligand inactivation Phase I, NCT02298387 Advanced solid tumor malignancies
REGN1979 Regeneron Pharmaceuticals Unclear CD20 × CD3 T cell recruitment Phase I, NCT02290951 CD20+ B cell malignancies
COVA322 Covagen IgG-fynomer TNF-α × IL17A Blockade of two proinflammatory cytokines Phase I/II, NCT02243787 Plaque psoriasis
RG7802 Hoffmann-La Roche CrossMab CEA × CD3 T cell recruitment Phase I, NCT02324257 Solid cancers
RG7813 (RO6895882) Hoffmann-La Roche ScFv-IgG CEA × IL2 The delivery of cytokines Phase I, NCT02004106 Advanced and/or metastatic solid CEA+ tumors
RG7221 (RO5520985) Hoffmann-La Roche CrossMAb Ang-2 × VEGF 2-ligand inactivation Phase II, NCT01688206 Neoplasms
RG7716 Hoffmann-La Roche CrossMAb VEGF × Ang-2 2-ligand inactivation Phase II,NCT02484690 Wet AMD
MM-111 Merrimack Pharmaceuticals HSA body HER2 × HER3 Blockade of 2 receptors Completed phase I, NCT01097460 Breast neoplasms
  Merrimack Pharmaceuticals    Blockade of 2 receptors Completed phase I, NCT00911898 Her2-amplified solid tumors
MM-141 Merrimack Pharmaceuticals scFv-IgG IGF-IR × HER3 Blockade of 2 receptors Phase I, NCT01733004 Hepatocellular carcinoma
      Phase II, NCT02399137 Pancreatic cancer
MOR209/ES414 Emergent Product Development Seattle LLC scFv-IgG PSMA × CD3 T cell recruitment Phase I, NCT02262910 Prostate cancer
TargomiRs University of Sydney Unclear EGFR × EDV Delivery of nanoparticles Phase I, NCT02369198 Recurrent MPM and NSCLC
MSB0010841 Merck KGaA Nanobody IL-17A/F Blockade of 2 proinflammatory cytokines Phase I, NCT02156466 Psoriasis
ALX-0061 Ablynx Nanobody IL-6R × HSA Blockade of proinflammatory cytokine, binds to HSA to increase half-life Completed phase I/II, NCT01284569 Rheumatoid arthritis
Ozoralizumab (ATN-103) Ablynx Nanobody TNF × HSA Blockade of proinflammatory cytokine binds to HSA to increase half-life Completed phase II, NCT01063803 Rheumatoid arthritis
AFM13 University of Cologne TandAb CD30 × CD16A Active NK cells Phase II, NCT02321592 Relapsed or refractory Hodgkin lymphoma
AFM11 Affimed GmbH TandAb CD30 × CD19 Redirecting of T cells Phase I, NCT02106091 Relapsed and/or refractory CD19-positive B cell NHL
SAR156597 Sanofi scFv-IgG IL4 × IL13 Blockade of proinflammatory cytokines Completed phase I/II, NCT01529853 Idiopathic pulmonary fibrosis
  Sanofi     Phase II, NCT02345070 Idiopathic pulmonary fibrosis
  1. bsAb bispecific antibody, ALL lymphoblastic leukemia, NHL non-Hodgkin lymphoma, wet AMD wet type age-related macular degeneration, MPM malignant pleural mesothelioma, NSCLC non-small-cell lung cancer